MitoQ for Cold Exposure

Overseen By Billie Alba, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Must not be taking: Antihypertensives, Statins

Disqualifiers: Cold injuries, Raynaud's, Asthma, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2.5 hours per session

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called MitoQ (Mitoquinone mesylate) can improve blood flow and skin temperature in cold conditions. The researchers aim to determine if MitoQ is particularly beneficial for Black individuals, who may face a higher risk of cold injuries like frostbite. Participants will take either MitoQ or a placebo before exposure to cold water or air. This trial suits healthy adults aged 18-40 who can avoid certain foods and drinks before testing and have no history of cold injuries or related conditions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on preventing cold injuries.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications or dietary supplements that could affect your heart, blood flow, or body temperature control, except for birth control.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MitoQ, the antioxidant tested in this trial, has been studied for its effects on cell damage caused by harmful molecules. Animal studies, such as those in mice and rats, have found that MitoQ can reduce oxidative stress. These studies suggest that MitoQ might be safe to use.

Although specific data from human studies on MitoQ for cold exposure is lacking, MitoQ is known to protect mitochondria, the cell parts that produce energy. This suggests MitoQ could be safe for humans, as studies have used it without major safety concerns. However, because this trial is in the "Not Applicable" phase, direct evidence of its safety in humans for this specific use is limited. Discuss participation and potential risks with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MitoQ for cold exposure because it offers a novel approach to managing the body's response to cold stress. Unlike standard treatments that focus on external warming or insulation, MitoQ targets cellular health by enhancing mitochondrial function. This antioxidant specifically combats oxidative stress within cells, potentially improving resilience to cold environments from the inside out. By directly supporting the mitochondria, MitoQ could offer a more effective and efficient way to maintain comfort and functionality in cold conditions.

What evidence suggests that MitoQ could be effective for improving skin temperature and blood flow in cold conditions?

This trial will evaluate the effects of MitoQ, a special antioxidant targeting the energy centers of cells, on cold exposure. Research has shown that MitoQ can enhance cellular function by reducing harmful substances. Studies have found that MitoQ lowers damaging oxidative stress, protects cells, and improves overall cell health. In this trial, participants will receive either MitoQ or a placebo before exposure to cold conditions. MitoQ might help maintain skin warmth and blood flow, which usually decrease in cold weather. Early results suggest that MitoQ could be more effective than common antioxidants like CoQ10 in certain situations. This may benefit individuals at risk of cold-related injuries, such as frostbite, by potentially improving skin and blood vessel function in cold conditions. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people who work in cold environments and are at risk of cold injuries like frostbite. It's particularly focused on understanding if Black individuals, who have a higher risk of such injuries, can benefit from an antioxidant supplement called MitoQ to improve skin temperature and blood flow.

Inclusion Criteria

Have supervisor approval if active-duty military or a federal employee at NSSC

I have regular menstrual cycles or use birth control pills or devices.

In good health as determined by OMSO (Office of Medical Support and Oversight)

Exclusion Criteria

Known allergy to MitoQ

Difficulty swallowing pills

I have skin color changes on a lot of my arms due to conditions like vitiligo or psoriasis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cold exposures following ingestion of MitoQ or placebo, including hand immersion in cold water and exposure to cold air.

2.5 hours per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of skin blood flow, temperature, and other physiological parameters.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitoquinone mesylate (MitoQ)

Trial Overview The study tests the effects of MitoQ supplementation versus a placebo on skin blood flow and temperature during exposure to cold conditions. Participants will immerse their hands in cold water or be exposed to cold air to simulate real-world conditions.

How Is the Trial Designed?

Group I: MitoQ - Cold Water Hand Immersion Experimental Treatment 2 Interventions

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Group II: MitoQ - Cold Air Exposure Experimental Treatment 2 Interventions

Four 20 mg MitoQ capsules (80 mg total) are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Group III: Placebo - Cold Water Hand Immersion Placebo Group 2 Interventions

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 30-minute hand immersion in 54°F water.

Group IV: Placebo - Cold Air Exposure Placebo Group 2 Interventions

Four placebo (microcrystalline cellulose) capsules are taken \~1 hour before a 90-minute cold exposure in 41°F air.

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+

Published Research Related to This Trial

A sensitive and accurate liquid chromatography/tandem mass spectrometry (LC/MS/MS) assay was developed to measure mitoquinone levels and its metabolites in rat plasma, demonstrating a linear calibration curve and a low limit of quantitation (0.5 ng/mL).

The pharmacokinetic study identified four metabolites of MitoQ10 in rat plasma, suggesting that MitoQ10 is effectively processed in the body, which is important for understanding its potential therapeutic effects in neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. Li, Y., Zhang, H., Fawcett, JP., et al.[2018]

Mitoquinone (MitoQ(10)) is effectively absorbed in the intestines, with 18-41% of the administered dose accumulating intracellularly, indicating its potential as a treatment for neurodegenerative diseases.

The absorption of MitoQ(10) can be significantly enhanced by the presence of serum proteins like bovine serum albumin, suggesting that its bioavailability may improve in real-life conditions despite some limitations from metabolism and transport proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. Li, Y., Fawcett, JP., Zhang, H., et al.[2018]

Mitoquinone (MitoQ), when added to University of Wisconsin preservation solution, significantly reduced oxidative damage and improved cell viability in kidneys subjected to cold storage, suggesting it could protect against tissue injury during organ preservation.

In a study involving isolated rat kidneys, MitoQ treatment completely prevented mitochondrial dysfunction and significantly improved renal morphology, indicating its potential to reduce kidney discardment and enhance renal function post-transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mitochondria-targeted antioxidant mitoquinone protects against cold storage injury of renal tubular cells and rat kidneys. Mitchell, T., Rotaru, D., Saba, H., et al.[2021]

MitoQ, a targeted antioxidant, effectively reduces oxidative DNA damage in T lymphocytes from older adults when exposed to oxidative stress, indicating its potential to improve immune function with age.

Higher concentrations of mitoQ (0.5 and 1.0 μM) significantly decreased endogenous DNA damage, suggesting that it may help combat age-related decline in immune cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of the effects of MitoQ on human peripheral mononuclear cells. Marthandan, S., Murphy, MP., Billett, E., et al.[2021]

MitoQ, a coenzyme Q10 derivative, significantly improves the post-thaw viability and functionality of cryopreserved buffalo skin fibroblasts, particularly at lower concentrations (0.1-0.5 μM), by reducing reactive oxygen species (ROS) and enhancing mitochondrial membrane potential (MMP).

Higher concentrations of MitoQ (2-10 μM) were found to be detrimental, increasing oxidative damage, highlighting the importance of dose management in using MitoQ for cell recovery after cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ ameliorates ROS production and improves cell viability in cryopreserved buffalo fibroblasts. Punetha, M., Saini, S., Chaudhary, S., et al.[2023]

MitoQ effectively reduces gentamicin-induced apoptosis in HEI-OC1 cells, indicating its potential to protect against hearing loss caused by aminoglycoside antibiotics.

Importantly, MitoQ does not compromise the antimicrobial efficacy of gentamicin, suggesting it could be a safe adjunct treatment to prevent ototoxicity while maintaining antibiotic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of gentamicin-induced apoptosis with the mitochondria-targeted antioxidant mitoquinone. Ojano-Dirain, CP., Antonelli, PJ.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06784531

The Influence of Race and MitoQ Supplementation on Skin ... The hypothesis is that the declines in skin blood flow and temperature will be greater during cold exposure in Black individuals and that MitoQ supplementation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5067250/

Long-term administration of the mitochondria-targeted ... In the present study, we report the effects of long-term administration of mitoquinone mesylate on muscle mass, morphology, and function; redox homeostasis; ...

3. mitoq.com mitoq.com/pages/research?srsltid=AfmBOop7J7SdrEGrHjW2SoueK3fxbV-oy46KZ-C_Vx-RBWfH8TMeqOxx

mitoquinol mesylate research studies & clinical trials After six weeks of supplementation, MitoQ was found to be 24% more effective than CoQ10 at reducing hydrogen peroxide levels in the mitochondria during states ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352289519300578

Involvement of oxidative stress and mitochondrial ... Simulated vehicle exhaust exposure is a source of toxicological stress. ... Prolonged exposure leads to behavioral deficits and elevated oxidative stress.

5. nature.com nature.com/articles/s41598-018-24949-0

MitoQ supplementation prevent long-term impact of ... MitoQ supplementation can mitigate the adverse impact of maternal SE on offspring's renal pathology, renal oxidative stress and mitochondrial density in mice ...

6. medchemexpress.com medchemexpress.com/Mitoquinone_mesylate.html?srsltid=AfmBOoqTw3YUSLhQJc7u8eYLFz0h8mPYq_olS8gMzI06a585ksyMzfG4

Mitoquinone mesylate (MitoQ mesylate) | Antioxidant Mitoquinone mesylate is a TPP-based, mitochondrially targeted antioxidant in order to protect against oxidative damage.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3382740/

The Mitochondria-Targeted Antioxidant Mitoquinone ... However, cold storage (CS) can result in tissue injury, kidney discardment, or long-term renal dysfunction after transplantation. We have previously determined ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S266713792100014X

Mitoquinol mesylate alleviates oxidative damage in ... In conclusion, our data suggest that Mitoquinol Mesylate (MitoQ) administration to cirrhotic-advanced HCC rats reduces oxidative stress by promoting ...